UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022558 |
|---|---|
| Receipt number | R000025971 |
| Scientific Title | Japanese Study of Bidirectional Evaluation of Surgical Performance on Cardiovascular Surgery-0 |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/05/31 20:15:34 |
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Basic information
Public title
Japanese Study of Bidirectional Evaluation of Surgical Performance on Cardiovascular Surgery-0
Acronym
jBLADE-0 Study
Scientific Title
Japanese Study of Bidirectional Evaluation of Surgical Performance on Cardiovascular Surgery-0
Scientific Title:Acronym
jBLADE-0 Study
Region
| Japan |
Condition
Condition
Diseases treated by Cardiovascular Surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this pilot study was to establish the standardized metrics to evaluate the technical skills of board eligible cardiovascular surgery residents performing basic cardiovascular surgical procedures including opening the chest, establishment of cardiopulmonary bypass, harvest of saphenous vein grafts, harvest of internal thoracic arteries, and closing the chest.
Basic objectives2
Others
Basic objectives -Others
Validation of evaluation system
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validation of standardized metrics determined by external evaluation committee
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Residents who is eligible for Japanese Cardiovascular Surgery Board Certification
2) Board Certified Cardiovascular Surgeons before first re-cirtification
Key exclusion criteria
Eligible surgeons who denied participating this study
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hashimoto |
Organization
The Jikei University School of Medicine
Division name
Department of Cardiac Surgery
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
kaz-hashi@jikei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Hashimoto |
Organization
The Jikei University School of Medicine
Division name
Department of Cardiac Surgery
Zip code
Address
3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
kaz-hashi@jikei.ac.jp
Sponsor or person
Institute
jBLADE study group
Institute
Department
Personal name
Funding Source
Organization
jCUTE
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
preinitiation
Management information
Registered date
| 2016 | Year | 05 | Month | 31 | Day |
Last modified on
| 2016 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025971
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
